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A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases

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Disease Information

Descriptive Information
Brief Title † A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
Official Title † An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases
Brief Summary The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Safety of D961H in terms of a panel of safety measures: adverse events, physical examination, vital signs and laboratory variables
Secondary Outcome Measure † Pharmacodynamic variabilities by assessment of the percentages of time with intragastric pH >4 and pH>3 (percent of the time)
Condition † Gastric Ulcer (GU) Duodenal Ulcer (DU) Anastomotic Ulcer (AU) Non-erosive Reflux Esophagitis Disease (NERD) Reflux Esophagitis (RE) Zollinger-Ellison Syndrome
Intervention † DrugD961H sachet 10 mg
Study Arms / Comparison Groups Group 1: D961H sachet 10 mg Age: ≥1 year Weight:
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 50
Start Date † June 2014
Completion Date February 2016
Primary Completion Date February 2016
Eligibility Criteria † Inclusion Criteria: - Provision of signed written informed consent from the patient's guardian - Patients aged ≥ 1 year to 14 years old - Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome. Exclusion Criteria: - Patients less than 10 kg in weight. - Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the randomisation/registration. - Significant clinical illness within 4 weeks prior to the registration - Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators. - Positive for pregnancy test by urinary or lactation for post-menarchal females. - Previous total gastrectomy
Gender Both
Ages 1 Year - 14 Years
Accepts Healthy Volunteers No
Contacts †† AstraZeneca Clinical Study Information Center, 1-877-240-9479, information.center@astrazeneca.com
Location Countries † Japan
Administrative Information
NCT ID † NCT02153398
Organization ID D961TC00002
Secondary IDs †† 26-022
Responsible Party Sponsor
Study Sponsor † AstraZeneca
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date October 2015
First Received Date † May 30, 2014
Last Updated Date October 1, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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